Korean J Med.
1999 Nov;57(5):906-915.
Korean multicenter clinical trial of simvastatin ( KS-1 study )
- Affiliations
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- 1Seoul National University Hospital
- 2SungKyunKwan University, Samsung Hospital, Korea.
- 3KyungHee University Hospital, Korea.
- 4Korea University, Anam Hospital, Korea.
- 5Gachon Colleage of medicine, Gil Hospital, Korea.
- 6Kyungpook National University Hospital, Korea.
- 7Keimyung University, Dongsan Hospital, Korea.
- 8Dong-A University Hospital, Korea.
- 9Pusan National University Hospital, Korea.
- 10Seoul National University, Boramae Hospital, Korea.
- 11Yonsei University, Severance Hospital, Korea.
- 12Ulsan University, Asan Hospital, Korea.
- 13Wonkwang University Hospital, Korea.
- 14Ewha Womans University, Tong Dae Mun Hospital, Korea.
- 15Inje University, Sangkei Paik Hospital, Korea.
- 16Chonnam National University Hospital, Korea.
- 17Chonbuk National University Hospital, Korea.
- 18Chosun University Hospital, Korea.
- 19Chungang University, Pil-dong Hospital, Korea.
- 20Chungnam National University Hospital, Korea.
- 21The Catholic University, St. Paul's Hospital, Korea.
- 22Hallym University, Kangdong Sacred Heart Hospital, Korea.
Abstract
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The aim of this study was to investigate the efficacy of simvastatin to improved lipid profiles
in hypercholesterolemic Korean patients.
METHODS
From 25 hospitals in Korea, 478 hypercholesterolemic patients were enrolled from November 1996 to April 1998. The inclusion criteria was hypercholesterolemia over 240 mg/dl after diet therapy for 1 month or hypercholesterolemia over 220 mg/dl in patients with definite evidence of ischemic heart disease. Simvastatin 10mg was started and doubled up to 40mg if total cholesterol level remained higher than 200 mg/dl at monthly check. Of 478 subjects, 344 patients in whom study protocol was not violated were analyzed.
RESULTS
Male to female ratio was 27:73 and 47% of the subjects were in 6th decade. Hypertension, coronary artery disease, and diabetes mellitus were present in 30, 10, and 4% of the subjects. Baseline lipid profile (mean of total cholesterol-LDL-HDL-triglyceride mg/dl) was 274-185-52-188. The dose of simvastatin for 3 months was 10/10/10mg in 61% of subjects, 10/20/20mg in 21%, 10/10/20mg in 7%, and 10/20/40mg in 12%. The change of total cholesterol level(before-4wk-8wk-12wk-withdrawal 4wk) was 274-209- 205-198-250, and the maximal reduction rate was 27%. The change of LDL-cholesterol was 185-123-116-110-159, with maximal reduction rate 39%. The change of HDL-cholesterol was 52-54-56-55-54, with maximal increase rate 9%. The change of tryglyceride was 188-161- 164-162-189, with maximal reduction rate 15%. The value before/after treatment of ApoA1, ApoB, and Lp(a) was 129/129, 138/83, and 9.3/10.7, respectively. The level of LDL-cholesterol at the end of treatment was below 100mg/dl in 36% of subjects, 100-130 in 45%, 130-160 in 16%, and over 160mg/dl in 4%. The reduction rate of LDL-cholesterol was different between subjects whose LDL decreased below 100 and those whose LDL did not decrease below 130mg/dl, which suggests the existence of the individual difference of responsiveness to simvastatin. There were only 3 subjects (0.9%) who showed increase of liver enzyme over 3 times as the upper normal limit. Conclusion: Simvastatin is effective in improving lipid profiles in hypercholesterolemic Korean patients without serious side effects.
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